Insomnia and other sleep problems are among the most common complaints dealt with by primary care physicians. Studies have estimated that 33% of the general population and up to 50% of older adults suffer from insomnia and other sleep-related disorders. The common treatments for insomnia are drugs such as zolpidem, temazepam, and doxepin as well as other anti-depressants and anxiolytics. Studies have estimated that these currently available treatments only improve sleep efficiency by <10% and improve total sleep time by less than 10%. Furthermore, the present treatments for insomnia have been associated with numerous deleterious and potentially dangerous side effects such as rebound insomnia upon withdrawal, drowsiness, parasomnias, and amnesia. These treatments typically produce central nervous system (CNS) sedation which prevents a normal arousal response to sleep-related gastroesophageal reflux (GER). This has been shown to result in a prolongation of acid mucosal contact which is a major cause of esophagitis. Thus, these treatments can exacerbate GER in individuals who may suffer from both insomnia and nighttime GER. Accordingly, an improved and safer treatment method for insomnia, particularly insomnia in GERD patients is needed.
Baclofen is a gamma-aminobutyric acid (GABA) receptor agonist that is primarily used to treat spasticity in patients with spinal cord injuries, cerebral palsy, and multiple sclerosis. Studies have demonstrated that baclofen also reduces GER and esophageal acid exposure in healthy individuals and patients with GERD. In addition, baclofen has been investigated as a potential treatment for restless legs syndrome (RLS) and obstructive sleep apnea (OSA). Some of these investigations noted an improvement in sleep parameters associated with improvement in the parameters of interest such as leg movements and obstructive breathing during sleep. The participants in these studies did not suffer from insomnia and the studies did not employ a transient insomnia protocol, therefore baclofen's efficacy as a sleep aid could not be assessed. Thus, to date, baclofen has not been assessed for efficacy in the treatment of individuals with insomnia.